Quality Control Chemist

About the role

The Quality Control Chemist is responsible for ensuring compliance with regulatory and accreditation standards, supporting regulatory inspections, and maintaining data integrity and laboratory quality systems.

Responsibilities

• Ensure compliance with Eagle Analytical policies and Standard Operating Procedures (SOPs).
• Interpret and apply regulatory and accreditation standards, including ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
• Support regulatory inspections, client audits, and accreditation assessments.
• Write, review, and approve SOPs, work instructions, forms, and quality records.
• Review and approve analytical test methods and related documentation.
• Review laboratory test reports, chemistry logs, worksheets, validation protocols, and validation reports.
• Ensure analytical data integrity, accuracy, completeness, and traceability.
• Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
• Evaluate root cause analyses and corrective action plans for process and laboratory-related issues.
• Create audit finding reports and determine appropriate corrective and preventive actions.
• Support and conduct internal audits of quality systems and documentation.
• Perform routine walk-through audits to ensure ongoing compliance across laboratory departments.
• Manage auditing, storage, and retention of quality documentation and quarantined materials.
• Prepare and maintain quality-related training materials as assigned.
• Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
• Assist in creating and maintaining quality manuals, procedures, and other controlled quality documents.
• Perform additional duties and special projects as assigned to support quality and regulatory objectives.

Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline.
• Experience in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
• Experience supporting analytical chemistry testing laboratories is strongly preferred.
• Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
• Working knowledge of method validation, data review, and laboratory quality systems.
• Experience reviewing GMP/GLP documentation and quality investigations.
• Strong attention to detail and commitment to data integrity and compliance.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Proficiency with Microsoft Office applications and electronic document management systems.
• ASQ certification preferred.

Skills

• Strong analytical skills.
• Attention to detail.
• Data integrity and compliance.
• Effective communication.
• Collaborative teamwork.

Behaviors

• Team Player: Works well as a member of a group.
• Dedicated: Devoted to a task or purpose with loyalty or integrity.
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well.

Qualifications

• Bachelor’s degree in Chemistry or related field.
• PREFERRED: Bachelor’s degree in Biochemistry or related field.

Benefits

Not specified.

Pay

Not specified.

Schedule

Not specified.